# K974454: Clearfield Anti-Fog Sterile Wipe, Product Number 300-004

- Pathway: 510(k) (Traditional)
- Applicant: Tucson Medical Corp.
- Decided: Dec 18, 1997 after 23 days
- Product code: OCT (Anti Fog Solution And Accessories, Endoscopy)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904871 (1991). 1 ancestor in all.
25 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904871: Medi-Kleer, North American Marketing Corp. (1991) Summary page 1.

## Most influential descendants
- K062779: Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp) (2006), 23 descendants of its own
- K080613: Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045 (2008), 16 descendants of its own
- K151117: Laparoscope Lens Shield Device (2015), 8 descendants of its own
- K160172: Laparoscope Lens Shield Device (2016), 7 descendants of its own
- K170103: Laparoscope Lens Shield Device (LENS) (2017), 6 descendants of its own

## Indications for use
ClearField Anti-Fog Sterile Wipe is intended for use as an agent to keep external viewing surfaces clear of water vapor and condensation.

Source page: https://510kreport.com/device/K974454
Methodology: https://510kreport.com/methodology